A Randomized Controlled Trial on the Effectiveness of Virtual Reality-assisted Executive Function Training in Autistic and ADHD Youth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Leiter-3
Study Overview
Brief Summary
This study aims to evaluate the effectiveness of a virtual reality-based intervention using the Virtual Reality Rehabilitation System (VRRS) to improve executive functions in autistic and ADHD youth aged 8 to 18 years. Executive functions, such as working memory, cognitive flexibility, and inhibitory control, are frequently impaired in individuals with autism and/or ADHD and significantly affect daily functioning. Participants will be randomly assigned to either an experimental group that receives VRRS-assisted cognitive training or a control group that receives treatment as usual. The intervention includes gamified tasks within immersive virtual environments specifically designed to stimulate executive skills. The primary outcome is the change in executive function scores from baseline to post-intervention, assessed using validated neuropsychological instruments. The study adopts a randomized controlled design.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 8 and 18 years at enrollment
- •Clinical diagnosis of Autism Spectrum Disorder and Attention- Deficit/Hyperactivity Disorder, based on DSM-5 criteria
- •Signed Informed consent provided by a parent or legal guardian;
- •No acute or chronic medical conditions
Exclusion Criteria
- •Age not between 8 and 18 years at enrollment
- •Lack of a clinical diagnosis of Autism Spectrum Disorder or Attention-Deficit/Hyperactivity Disorder
- •Failure to sign informed consent from a parent or legal guardian;
- •Presence of acute or chronic medical conditions
Arms & Interventions
VRRS Cognitive Training
The intervention consists of 20 individual sessions using the Virtual Reality Rehabilitation System (VRRS). Each session lasts 45 minutes and is held biweekly. The project aims to stimulate and improve memory and executive functions, such as planning and attention, in children with ASD and ADHD. The VRRS platform integrates semi-immersive and interactive cognitive exercises in a virtual environment, increasing engagement and motivation. Tasks are progressively adapted to the participant's level and performance.
Intervention: VRRS Cognitive Training (Behavioral)
Treatment As Usual
Participants in this group will begin traditional CBT intervention without the use of virtual reality technology.
Intervention: Treatment as Usual (TAU) (Behavioral)
Outcomes
Primary Outcomes
Leiter-3
Time Frame: T0(baseline)-T1(6months)
The Leiter-3 is a nonverbal, standardized cognitive assessment tool designed to evaluate intellectual functioning, attention, and memory in children and adolescents. In this study, selected subtests from the Leiter-3 will be used not only to estimate nonverbal IQ, but also to assess attentional control and memory capacity at both baseline and post-intervention. Administering the Leiter-3 at T0 and T1 allows for the comparison of pre- and post-intervention cognitive functioning without the confounding effects of language. Scaled scores from the Reasoning, Attention/Memory, and Processing Speed subdomains will be analyzed.
Tower of London
Time Frame: T0(baseline)-T1(6months)
The Tower of London (ToL) is a standardized neuropsychological test used to assess higher-order executive functions, particularly planning, problem-solving, and working memory.
NEPSY-II
Time Frame: T0(baseline)-T1(6months)
Subtests from the NEPSY-II (e.g., Auditory Attention and Response Set, Inhibition) will be administered to evaluate selective attention, sustained attention, cognitive flexibility, and the ability to shift between task demands. These measures are developmentally appropriate and widely used to detect attentional and executive control difficulties in children and adolescents with neurodevelopmental conditions.
Secondary Outcomes
- Conners Rating Scales(T0(baseline)-T1(6months))
- Child Behavior Checklist (CBCL)(T0(baseline)-T1(6months))
- Short Sensory Profile (SSP)(T0(baseline)-T1(6months))
- Repetitive Behavior Scale-Revised (RBS-R)(T0(baseline)-T1(6months))
- Quality of Life in Autism Questionnaire (QoLA)(T0(baseline)-T1(6months))